Binge Eating Disorder and Obesity Resulting from Binge Eating Disorder
Binge Eating Disorder is a form of Eating Disorder Not Otherwise Specified according the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR). As defined by the DSM-IV-TR, it is characterized by recurrent binge eating episodes.
Commonly described symptoms of binge eating disorder include frequent dieting and weight loss, hoarding of food, hiding empty food containers, eating late at night, attribution of one's successes and failures to weight, avoiding social situations where food may be present, and feeling depressed or anxious. Binge eating also may cause rapid and unhealthy weight gain (or loss), weight fluctuations, and chronic erratic eating behavior. Binge eating disorder and symptoms associated with binge eating disorder may result in obesity though obesity is not necessarily a result of binge eating disorder. Further, patients with binge eating disorder are often not obese and may even have a below normal weight.
The biological basis of binge eating disorder is poorly understood. Binge eating disorder is difficult to treat and carries significant medical and psychiatric risks. Pharmacologic interventions have been of limited success and sometimes cause a worsening of binge eating symptoms. A number of psychotropic medications, including but not limited to antidepressants, antipsychotics, antimanic agents, and mood modulating medications are known to cause binge eating, dysregulation of appetite, and weight gain. Binge eating behaviors and weight gain may be a direct effect of such medication(s). Psychotropic medications may also exacerbate an underlying binge eating disorder in some patients.
Medical complications associated with binge eating disorder include high blood pressure, high cholesterol and triglycerides, kidney disease (and failure), gallbladder disease, arthritis, bone deterioration, stroke, upper respiratory infections, skin disorders, menstrual irregularities, ovarian abnormalities, and pregnancy complications. Psychiatric problems associated with, or exacerbated by, binge eating disorder include depressive disorders, mood disorders, anxiety disorders, ADHD and ADD, personality disorders, other eating disorders, suicidal thoughts, and substance abuse disorders.
Individuals with binge eating disorder may respond to treatment with antidepressants, though such medications may contribute to a worsening of binge eating symptoms, along with weight gain, either at the outset of treatment or over time.
Depression
Depression is often difficult to treat, as some patients fail to respond to an initial pharmacologic intervention and a decision must be made to switch agents, augment with another medication(s), or combine multiple pharmacologic agents. Combining medications, while often helpful, can sometimes be problematic with added side effect burdens. Side effects of certain psychotropic medication sometimes used to offer adjunct treatment to patients already taking antidepressants may include weight gain and obesity.
Individuals treated for major depressive disorders may show a positive response or full remission of symptoms to medication treatment, though recent clinical evidence suggests remission rates following an adequate course of monotherapy treatment may as low as 30-40%. Further, clinical studies suggest an unusually large percentage of depressed individuals treated with antidepressant medication, greater than 30-40% in various clinical studies, show only a partial response (for example, full remission is not achieved but there is some measure of improvement in depressive symptoms). Some patients may be ‘refractory’ or ‘resistant’ to treatment and fail to respond to one, or in some cases, multiple monotherapy and combination antidepressant medication treatments.
Major depressive disorders similarly may lead to deteriorating physical health and may increase the risk of morbidity and mortality in patients with concurrent medical conditions.
Similarly, depressive disorders are often associated with, or may exacerbate, other mood disorders, anxiety disorders, attention deficit hyperactivity disorder (ADHD or ADD), psychotic disorders, personality disorders, eating disorders, cognition and cognitive disorders, substance abuse disorders, and suicidal ideation.
There exists an unmet and important clinical need for treatments for binge eating disorders, obesity resulting from binge eating behavior, and depression that is only partially responsive to medication and intractable (e.g. ‘treatment-resistant’) depression. The present invention fulfills this need and provides additional advantages described herein.